US20170086956A1 - Foldable Pessary for Treatment of Stress Urinary Incontinence - Google Patents
Foldable Pessary for Treatment of Stress Urinary Incontinence Download PDFInfo
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- US20170086956A1 US20170086956A1 US14/870,471 US201514870471A US2017086956A1 US 20170086956 A1 US20170086956 A1 US 20170086956A1 US 201514870471 A US201514870471 A US 201514870471A US 2017086956 A1 US2017086956 A1 US 2017086956A1
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- Prior art keywords
- pessary
- vagina
- bridge
- mid
- support
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/005—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0017—Angular shapes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0019—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
Definitions
- the present invention may be a method of treating stress urinary incontinence having the steps of providing a pessary dimensioned to extend across opposing walls of a vagina and having a first end having a first support knob opposite a second end having a second support knob and a bridge extending along a first axis and arching along a second axis substantially perpendicular to the first axis between the first and second ends to provide a substantially incompressible structure configured to bend allowing pinching of the first and second ends together, pinching the first and second ends together to allow insertion into the vagina; inserting the pessary approximately 1-2 cm within the opening of the vagina; and releasing the first and second ends of the pessary while the pessary is in the vagina to allow the first and second support knobs to separate to contact opposing walls of the vagina and the bridge to arch toward a posterior sidewall of the vagina to allow an underside of the bridge to support the mid-urethra.
- the pessary may provide a flexure such that the first and second ends may reversibly contact one another.
- the pessary may provide a flexure of one of the first and second ends of at least 3 cm with an oblique force of less than 200 grams when the other of the first and second ends is stationary.
- the present invention may be a pessary device for treating stress urinary incontinence having a bridge support extending along a first axis between a first end and a second end of the bridge support and arching along a second axis perpendicular to the axis; a first grip portion at the first end and extending perpendicularly to the first and second axes and configured to engage a sidewall of a vagina; and a second grip portion at the second end and extending perpendicularly to the first and second axes and configured to latch onto an opposing sidewall of the vagina; where the bridge support is elastically deformable to bend at substantially a midpoint and to provide an outward force at the opposing first and second ends.
- the present invention may be a pessary device for treating stress urinary incontinence having a bridge dimensioned to extend across a human vaginal canal and having a first and second end configured to contact opposing sidewalls of the vaginal canal; where the bridge is made of a substantially incompressible elastomer and configured to flex at substantially a midpoint of the bridge to allow insertion of the device into the vagina and to unflex to a length greater than the width of the vaginal canal to allow the first and second end to grip opposing sidewalls of the vaginal canal.
- a pessary 20 for example, of a substantially incompressible elastomer such as a medical-grade silicone, silicone rubber, or rubber, may be defined by a bridge 22 structure extending generally along an axis 24 and having a height of substantially 1.0 cm and between 1.0-2.0 cm, a length of substantially 3.0 cm and between 2.0-4.0 cm, and a width of substantially 1.0 cm and between 1.0-2.0 cm.
- a first end 26 of the pessary 20 may be positioned opposite a second end 28 of the pessary 20 with each end having support knobs 30 , 32 for facilitating attachment to a vaginal wall 70 , to be further described below.
- the vagina 52 provides a passageway from an opening 54 or introitus of the vagina 52 to the cervix 56 of the uterus 58 .
- the vagina 52 is defined by inner walls 70 providing an upper wall 72 , lower wall 73 , and left 74 and right 76 sidewalls.
- An anus 60 and rectum 62 are posterior to the vagina 52 .
- the shape of the pessary 20 is able to translate the forces applied to the mid-section 34 to the generally opposing first and second ends 26 , 28 in a generally perpendicular direction from the original forces.
- the forces applied to the mid-section 34 may be used to help maintain or support the pessary 20 at the walls 70 of the vagina 52 .
- the pessary 20 uses its own unique shape to prevent it from falling out or rotating from its original position without reliance on vaginal notches or a large or more expansive pessary 20 design.
- the pessary 220 may take a bridge 222 configuration with a generally straight or slightly concave mid-section 234 .
- the mid-section 234 may be flanked by downwardly extending first 226 and second 228 ends.
- the first 226 and second 228 ends may be bowed outward to provide a generally concave shape in accordance with an outline of the vaginal walls 70 .
- the first and second 226 , 228 ends way extend a distance at least half the length of the pessary 220 to provide a greater attachment surface than the other embodiments.
Abstract
The present invention provides a vaginal pessary that offers mid-urethral support and is supported laterally near the vaginal opening, rather than between the apex of the vagina and the back of the pubic bone as is found in current pessaries. The pessary is inserted closer to the opening of the vagina so that it will support the mid-urethra, rather than the bladder neck, in accordance with the new understanding of the importance of mid-urethral support. The pessary is smaller and applies minimal force along the inner walls of the vagina.
Description
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- The present invention relates to vaginal pessaries for treating stress urinary incontinence.
- Accidental urinary leakage affects more than half of independent women aged 65 and older in the United States. Stress urinary incontinence is the most prevalent type of urinary incontinence, present in over 80% of urinary incontinence cases. Stress urinary incontinence is defined by leakage associated with activities that increase intra-abdominal pressure, such as when coughing, sneezing, and during physical activity. Pelvic floor muscle strengthening, vaginal pessaries, and mid-urethral sling surgery are common treatment options for those suffering from stress urinary incontinence.
- Pelvic floor muscle strengthening exercises are done by flexing the muscles used to stop urination. When exercises are maintained, pelvic floor muscle strengthening exercises are shown to be effective in treating stress urinary incontinence in just over half of women in the short term. However, many women discontinue their exercises over time.
- Pessaries are vaginally inserted devices that are used to treat pelvic organ prolapsed as well as urinary incontinence. Current pessaries for treating urinary incontinence are commonly ring-shaped devices placed with one end against the cervix of the vagina and the more distal end against the top vaginal wall. The more distal end is intended to support the area beneath the bladder neck of the urethra. Current vaginal pessaries operate on the belief that loss of support of the bladder neck contributed to the cause of stress urinary incontinence. Current pessaries are shown to improve the symptoms of about half of women.
- Through a better understanding of the underlying pathophysiology of stress urinary incontinence, it has been found that support of the urethra, not just the bladder neck, may be important for treating stress urinary incontinence. Mid-urethral sling surgery draws on this idea by using a synthetic mesh to provide “sling” support underneath the mid-urethra where the weakened pelvic floor muscles previously provided support. Mid-urethral sling surgery has proven to be the most effective treatment so far for treating stress urinary incontinence, resulting in improvement in over 90% of women who undergo the surgery.
- Despite the success of mid-urethral sling surgery, the surgery may not be an available option to all women and others may not wish to undergo the invasive surgery.
- The present inventors have recognized that it is possible to produce a vaginal pessary that offers appropriate mid-urethral support and is supported laterally near the vaginal opening, rather than between the apex of the vagina and the back of the pubic bone as is found in current pessaries. The new vaginal pessary is inserted closer to the opening of the vagina so that it will support the mid-urethra, rather than the bladder neck, in accordance with the new understanding of the importance of mid-urethral support.
- In one embodiment, the present invention may be a method of treating stress urinary incontinence having the steps of providing a pessary dimensioned to extend across opposing walls of a vagina and having a first end having a first support knob opposite a second end having a second support knob and a bridge extending along a first axis and arching along a second axis substantially perpendicular to the first axis between the first and second ends to provide a substantially incompressible structure configured to bend allowing pinching of the first and second ends together, pinching the first and second ends together to allow insertion into the vagina; inserting the pessary approximately 1-2 cm within the opening of the vagina; and releasing the first and second ends of the pessary while the pessary is in the vagina to allow the first and second support knobs to separate to contact opposing walls of the vagina and the bridge to arch toward a posterior sidewall of the vagina to allow an underside of the bridge to support the mid-urethra.
- It is thus a feature of at least one embodiment of the invention to provide easier insertion of the pessary near the opening of the vagina rather than near the cervix and to provide support at the mid-urethra. Insertion of the present invention generally would not require a lubricant.
- The pessary in a relaxed state may be bounded by a rectangle coplanar with the first and second axis and wider than it is tall. The pessary in a relaxed state may have a height and length with an aspect ratio of substantially 1:3.
- It is thus a feature of at least one embodiment of the invention to use the shape of the pessary to translate the forces on the pessary to produce lateral forces to hold the pessary in place.
- The pessary may provide a flexure such that the first and second ends may reversibly contact one another.
- It is thus a feature of at least one embodiment of the invention to provide a pessary that does not require exact fit within the vagina by using an arch that springs out to conform to the vaginal canal.
- The pessary may provide a flexure of one of the first and second ends of at least 3 cm with an oblique force of less than 200 grams when the other of the first and second ends is stationary.
- It is thus a feature of at least one embodiment of the invention to apply minimal contact to the vaginal walls to increase comfort.
- The pessary may be an elastomer that is a silicone rubber. The pessary may have a hardness between 30-40 durometer.
- It is thus a feature of at least one embodiment of the invention to create a compact and adaptable pessary by using a material that can withstand repeated flexing with good resilience.
- The pessary may have a length defined by the distance between the first and second ends of between 2.5-3.5 cm.
- It is thus a feature of at least one embodiment of the invention to provide a smaller, more compact pessary. The pessary is sized to fit within and extend across the vagina of an average adult female human.
- There may be additional pessaries providing a kit of pessaries, each pessary defining a different length for insertion in different sizes of vaginas.
- It is thus a feature of at least one embodiment of the invention to provide multiple sizes for proper fitting in different sized vaginal canals, for example, for comfort, to prevent the pessary from falling out, and to apply the appropriate support force.
- In another embodiment, the present invention may be a pessary device for treating stress urinary incontinence having a bridge support extending along a first axis between a first end and a second end of the bridge support and arching along a second axis perpendicular to the axis; a first grip portion at the first end and extending perpendicularly to the first and second axes and configured to engage a sidewall of a vagina; and a second grip portion at the second end and extending perpendicularly to the first and second axes and configured to latch onto an opposing sidewall of the vagina; where the bridge support is elastically deformable to bend at substantially a midpoint and to provide an outward force at the opposing first and second ends.
- It is thus a feature of at least one embodiment of the invention to provide support knobs that provide a toe-hold grip on the vaginal walls and prevent torsion.
- The first and second grip portions may have a cross section that is at least 1.5 times as wide as it is tall.
- The pessary may have a height of the bridge support defined by the distance between a top of the mid-section and the bottom of the first and second ends of approximately 1 cm.
- In another embodiment, the present invention may be a pessary device for treating stress urinary incontinence having a bridge dimensioned to extend across a human vaginal canal and having a first and second end configured to contact opposing sidewalls of the vaginal canal; where the bridge is made of a substantially incompressible elastomer and configured to flex at substantially a midpoint of the bridge to allow insertion of the device into the vagina and to unflex to a length greater than the width of the vaginal canal to allow the first and second end to grip opposing sidewalls of the vaginal canal.
- It is thus a feature of at least one embodiment of the invention to use the natural resistance of the vaginal tissue to brace the pessary against the vaginal walls.
- The bridge may form a substantially obtuse angle when inserted into the vagina.
- The bridge may be configured to flex to form a substantially acute angle to allow insertion of the device into the vagina.
- The midpoint of the bridge may contact the sidewall of the vaginal canal.
- These particular objects and advantages may apply to only some embodiments falling within the claims and thus do not define the scope of the invention.
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FIG. 1 is a perspective view of a pessary of the present invention shown generally from above; -
FIG. 2 is a figure similar toFIG. 1 showing the pessary shown generally from below; -
FIG. 3A-3D is a front elevation view, left side elevation view, bottom plan view, and right side elevation view of the pessary ofFIG. 1 ; -
FIG. 4A-4C is the pessary ofFIG. 1 flexed at a mid-section before insertion of the device into the vagina, and showing three different sizes that would come in a pessary kit; -
FIG. 5 is a cross-section of the female anatomy showing the pessary inserted near the opening of the vagina and showing the intra-abdominal pressures applied to the region; -
FIG. 6 is an inferior view of the vaginal opening and showing the pessary inserted in the vagina and showing the forces applied to the urethra such that the pessary supports the mid-urethra; -
FIG. 7 is a perspective view of the female anatomy showing the mid-urethra being supported from behind by the pessary inserted into the vagina; -
FIG. 8 is an alternative embodiment of a pessary of the present invention taking a “U-shaped” configuration and a mesh spanning the two ends with suction cups at the pessary ends; -
FIG. 9 is an alternative embodiment of a pessary of the present invention taking an inverted “U-shaped” configuration with bowed out arms and slightly concave mid-section; and -
FIG. 10 is an alternative embodiment of a pessary taking a rounded “W-shaped” configuration. - Referring now to
FIGS. 1 and 2 , apessary 20, for example, of a substantially incompressible elastomer such as a medical-grade silicone, silicone rubber, or rubber, may be defined by abridge 22 structure extending generally along anaxis 24 and having a height of substantially 1.0 cm and between 1.0-2.0 cm, a length of substantially 3.0 cm and between 2.0-4.0 cm, and a width of substantially 1.0 cm and between 1.0-2.0 cm. Afirst end 26 of thepessary 20 may be positioned opposite asecond end 28 of thepessary 20 with each end havingsupport knobs vaginal wall 70, to be further described below. As used herein, incompressible means that during flexing, the volume of thepessary 20 is substantially constant as opposed to a foam material or the like. As such thepessary 20 when properly braced in an arched form can resist compression forces until a buckling point. - The
pessary 20 may be a medical-grade silicone rubber commercially provided by, e.g., Dow Corning, Blue Star Silicone or Applied Silicone, which is biocompatible, easy to clean, and safe for medical applications. The medical-grade silicone rubber allows the material to flex at generally a mid-point when inward force is applied to theends pessary 20. The resilience of the medical-grade silicone rubber allows for repeated flexing of thepessary 20 without losing its ability to rebound back to its original shape and size. It is contemplated that thepessary 20 may be durable enough to be used daily (for at least 12 hours) and to be taken out at night, for a duration of at least ninety days. - Referring also to
FIGS. 3A-3D , in one embodiment of the invention thebridge 22 may take an inverted arch configuration, extending a distance between the first and second ends 26, 28. A mid-section 34 of thebridge 22 extends outwardly along anaxis 36 substantially perpendicular to theaxis 24 to form an inverted arched central portion. Opposite distal ends of the mid-section 34 are flanked by the first and second ends 26, 28 of thepessary 20, respectively. Thefirst end 26 andsecond end 28 extend substantially along theaxis 24 to provide generally opposing lateral forces to theperpendicularly extending mid-section 34. - The
first end 26 may provide afirst support knob 30 and thesecond end 28 may provide asecond support knob 32 for facilitating an attachment to thevaginal walls 70. The support knobs 30, 32 may be defined as cylindrical pads with abody section 46 extending along anaxis 48 of the cylinder perpendicular toaxes cross-sectional front 42 and rear 44 ends. Thebody section 46 extends along the width of thepessary 20 defined by a distance between afront side 38 and arear side 40 of thepessary 20 with the front ends 42 substantially aligned with thefront side 38 of the pessary and a rear ends 44 substantially aligned with therear side 40 of the pessary. The support knobs 30, 32 may also extend past thefront side 38 andrear side 40 to provide a longer gripping surface. Thebody section 46 of the support knobs 30, 32 provides a curved, outwardly protruded surface for comfortably applying concentrated pressure to thevaginal walls 70. When thebody section 46 is cut alongaxis 48 perpendicular toaxis 24, it has a cross section wider than it is tall, for example, 1.5-2 times wider than it is tall, to prevent torsion of thepessary 20 within the vaginal canal. - Referring to
FIG. 3A , thepessary 20 may be sized such that in a relaxed state and when placed within a rectangle, the rectangle is wider than it is tall. The rectangle may have an aspect ratio of 3:1 or 3:2. The angle formed by the first and second ends 26, 28 may form an obtuse angle when un-flexed or relaxed, such as when installed within thevagina 52. When flexed, the angle formed by the first and second ends 26, 28 may form an acute angle, seeFIG. 4A-4C . - Referring to
FIG. 5 , a cross-sectional representation of the average femalehuman anatomy 50 is shown with the “anterior” referring to the front of the human body, the “posterior” referring to the back of the human body, the “left lateral” referring to the left side of the human body, and the “right lateral” referring to the right side of the human body. As is generally understood in the art, thevagina 52 provides a passageway from anopening 54 or introitus of thevagina 52 to the cervix 56 of theuterus 58. Thevagina 52 is defined byinner walls 70 providing anupper wall 72,lower wall 73, and left 74 and right 76 sidewalls. Ananus 60 andrectum 62 are posterior to thevagina 52. Aurethra 64 andurinary bladder 66 are anterior to thevagina 52. Theurethra 64 provides amid-urethral section 65 or sub-urethral section substantially mid-way between theurethral opening 63 and theurinary bladder 66, and abladder neck 67 or base below theurinary bladder 66 but above themid-urethral section 65. Thepubic bone 68 is anterior to theurethra 64 andurinary bladder 66 and creates a notch 71 in the uppervaginal wall 72 behind thepubic bone 68 where it protrudes. - Referring to
FIG. 4A-4C , thepessary 20 may be inserted within the humanfemale vagina 52 by pinching or applying inward forces to the first and second ends 26, 28 so that thepessary 20 flexes at substantially a mid-point of thepessary bridge 22 and the first and second ends 26, 28 come together. The length of thepessary 20 when flexed is decreased such that thepessary 20 may be easily inserted into thevaginal opening 54. - Referring to
FIG. 5 , thepessary 20 may be inserted substantially 1 cm and between 1-2 cm into theopening 54 of thevagina 52. In another embodiment, thepessary 20 may be inserted substantially 2 cm and between 1-2 cm below the protrusion 71 created by thepubic bone 68. Thepessary 20 is oriented such that the convex side of the mid-section 34 extends toward thelower wall 73 of thevagina 52 adjacent therectum 62. The underside or concave side of the mid-section 34 faces the oppositeupper wall 72 of thevagina 52 posterior and adjacent to theurethra 64. The first and second ends 26, 28 contact the left 74 and right 76 sidewalls of the vagina at the left and right laterals of the human body, respectively. Due to the symmetry of thepessary 20, it is understood that thepessary 20 may be rotated so that the first and second ends 26, 28 are switched and contact the opposite of the left andright sidewalls pessary 20 may be inverted so that the concave side of the mid-section 34 extends toward thelower wall 73 and the convex side faces the oppositeupper wall 72. Thepessary 20 may be inverted, for example, to apply greater passive support at themid-urethral section 65. - Once the
pessary 20 is inserted to the desired depth and orientation within thevagina 52, the force applied to the first and second ends 26, 28 are released so that thepessary 20 relaxes to its relaxed state and the support knobs 30, 32 contact theinner walls 70 of thevagina 52. The support knobs 30, 32 produce a “toe-hold” attachment to theinner walls 70 with minimal discomfort. Thebody section 46 may extend along the vaginal canal to prevent twisting of thepessary 20 or unwanted movement. Thebody section 46 also distributes the pressure placed on thevaginal walls 70. - Referring also to
FIGS. 6-7 , when inserted in thevagina 52, the mid-section 34 of thepessary 20 is positioned substantially behind and below themid-urethral section 65 of theurethra 64. In this position, thepessary 20 acts as a backstop to passively support the mid-urethra 65 underneath the mid-urethra 65 when intra-abdominal pressure places downward forces on the urethra, such as during physical activity. In this respect, thepessary bridge 22 acts as a substitute “sling” by supporting underneath the mid-urethra 65 through the uppervaginal wall 72 adjacent the urethra 64 instead of requiring a surgical sling extending around the mid-urethra 65 as found in mid-urethra sling surgery. - Referring to
FIG. 6 , thepessary 20 is able to brace itself against thevaginal walls 70 through the translation of forces against the mid-section 34 of thebridge 22 to the first and second ends 26, 28 and the slight elongation of thevagina 52. When thepessary 20 is inserted, the first and second ends 26, 28 extend outward laterally against thevaginal walls 70, utilizing the natural resistance of thevaginal walls 70 to produce a snug fit. When intra-abdominal pressure is applied to the urethra, additional forces are exerted at or near the mid-section 34 of thepessary 20 located behind the mid-urethra 65. The shape of thepessary 20 is able to translate the forces applied to the mid-section 34 to the generally opposing first and second ends 26, 28 in a generally perpendicular direction from the original forces. Thus, the forces applied to the mid-section 34 may be used to help maintain or support thepessary 20 at thewalls 70 of thevagina 52. In this respect, thepessary 20 uses its own unique shape to prevent it from falling out or rotating from its original position without reliance on vaginal notches or a large or moreexpansive pessary 20 design. - By utilizing limited points of contact at the
vaginal walls 70, thepessary 20 may provide increased comfort to the user. However, it is contemplated that additional support knobs may be added to the device to increase the points of contact along thevaginal walls 70. Also, the support knobs 30, 32 may be enlarged or extended in size to increase the contact area of the knobs against thevaginal wall 70, thus improving the hold of thepessary 20 to thevaginal wall 70. - The
pessary 20 is sized to arch thevagina 52 near theopening 54 of thevagina 52 which may generally have a smaller diameter than deeper in thevagina 52. For example, an average width of thevaginal opening 54 in an average adult woman is approximately 2.62 cm, which is less than the average width at the pelvic diaphragm—2.78 cm—or at the proximal vagina-3.25 cm. Therefore, thepessary 20 may be smaller and less intrusive than pessaries that are configured to fit deeper within thevagina 52 where the width is generally greater than the introitus diameter. In this respect, thepessary 20 is sized slightly larger than the vaginal width so that it may be maintained within falling out but not too large as to exert too much pressure on thevaginal walls 70. - Referring to
FIGS. 4A-4C , the present invention may provide a kit of more than onepessary 20, each pessary being a different size to accommodate varying widths of the vaginal opening. The user may select aparticular pessary 20 depending on the fit of thepessary 20 in thevagina 52 so that it does not fall out or apply too much pressure. The kit may come withvaginal pessaries 20 of varying lengths, such as substantially 2.5 cm (small), 3 cm (medium) and 3.5 cm (large), or a length of between 1-2 cm larger than the introital diameter of the user's vagina. - Insertion of the
pessary 20 may be facilitated by an applicator (not shown), which automatically flexes thepessary 20 before and during insertion into thevagina 52. Once thepessary 20 is inserted, the applicator may remove force on thepessary 20 ends to allow thepessary 20 to un-flex. The applicator may include an insertion member and a plunger. The insertion member may include thepessary 20, which is expelled by the plunger when the insertion member is in the proper position. - Removal of the
pessary 20 may be facilitated by a cord or string (not shown) attached to thepessary 20 which allows the user to pull the string to remove thepessary 20 from thevagina 52. The string may be attached, for example, at the first and second ends 26, 28, respectively, such that pulling the string also causes thepessary 20 to flex facilitating the removal of the device. - Referring to
FIG. 8 , in an alternative embodiment, thepessary 120 may take abridge 122 configuration with a first 126 and second 128 end and a mid-section 134 which makes an inverted arch or “U-shape.” The ends 126, 128 may be flanked by amesh 180 extending between the first 126 and second 128 ends to provide support on forces perpendicular to themesh 180. Themesh 180 may be a flexible and thin medical-grade silicone. - Similarly, the
pessary 120 may be folded at substantially amid-section 134 of thebridge 122 by applying force to theends pessary 120 may be inserted such that thearched mid-section 134 extends toward thelower wall 73 of thevagina 52 and themesh 180 extends toward theupper wall 72 of thevagina 52. The first and second ends 26, 28 contact the left 74 and right 76 sidewalls of the vagina at the left and right laterals of the human body, respectively. Themesh 180 is positioned behind and under amid-urethral section 65 of the urethra 64 so as to provide passive support to the mid-urethra 65 when under pressure. It is understood thatmesh 180 may used in any of the pessary embodiments described herein. - In the alternative embodiment, the
ends suction cups 182 to assist in the attachment of theends vaginal wall 70. It is understood that suction cups 182 may be applied to the ends of any of the pessary embodiments described herein. - Referring to
FIG. 9 , in an alternative embodiment, thepessary 220 may take abridge 222 configuration with a generally straight or slightlyconcave mid-section 234. The mid-section 234 may be flanked by downwardly extending first 226 and second 228 ends. The first 226 and second 228 ends may be bowed outward to provide a generally concave shape in accordance with an outline of thevaginal walls 70. The first and second 226, 228 ends way extend a distance at least half the length of thepessary 220 to provide a greater attachment surface than the other embodiments. - Again, the
pessary 220 may be folded at substantially amid-section 234 of thebridge 222 by applying force to theends pessary 220 may be inserted such that the straight orconcave mid-section 234 extends toward theupper wall 72 of thevagina 52 and the first and second ends 226, 228 contact the left 74 and right 76 sidewalls of the vagina at the left and right laterals of the human body, respectively. Themid-section 234 of thepessary 220 is positioned behind and under amid-urethral section 65 of the urethra 64 so as to provide passive support to the mid-urethra 65 when under pressure. - Referring to
FIG. 10 , in an alternative embodiment, thepessary 320 may take abridge 322 configuration with a generally curved “W-shaped” configuration whereby the arched middle section of the “W” extends upwardly to provide acurved mid-section 334. - Again, the
pessary 320 may be folded at substantially acurved mid-section 334 of thebridge 322 by applying force to theends pessary 320 may be inserted such that thecurved mid-section 334 extends toward theupper wall 72 of thevagina 52 and the first and second ends 326, 328 extend toward theupper wall 72 of the vagina to generally contact the left 74 and right 76 sidewalls of the vagina at the left and right laterals of the human body, respectively. Themid-section 234 of thepessary 220 is positioned behind and under amid-urethral section 65 of the urethra 64 so as to provide passive support to the mid-urethra 65 when under pressure. The first and second ends 326, 328 may be inserted such that the ends 326, 328 latch into indentations of theupper wall 72 of thevagina 52. - Certain terminology is used herein for purposes of reference only, and thus is not intended to be limiting. For example, terms such as “upper”, “lower”, “above”, and “below” refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, “bottom” and “side”, describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second” and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.
- When introducing elements or features of the present disclosure and the exemplary embodiments, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of such elements or features. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements or features other than those specifically noted. It is further to be understood that the method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.
- It is specifically intended that the present invention not be limited to the embodiments and illustrations contained herein and the claims should be understood to include modified forms of those embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims. All of the publications described herein, including patents and non-patent publications, are hereby incorporated herein by reference in their entireties.
Claims (20)
1. A method of treating stress urinary incontinence comprising the steps of:
providing a pessary dimensioned to extend across opposing walls of a vagina and having a first end having a first support knob opposite a second end having a second support knob and a bridge extending along a first axis and arching along a second axis substantially perpendicular to the first axis between the first and second ends to provide a substantially incompressible structure configured to bend allowing pinching of the first and second ends together;
pinching the first and second ends together to allow insertion into the vagina;
inserting the pessary approximately 1-2 cm within the opening of the vagina; and
releasing the first and second ends of the pessary while the pessary is in the vagina to allow the first and second support knobs to separate to contact opposing walls of the vagina.
2. The method of claim 1 wherein the pessary in a relaxed state is bounded by a rectangle coplanar with the first and second axis and wider than it is tall.
3. The method of claim 1 wherein the height and length have an aspect ratio of substantially 1:3.
4. The method of claim 1 wherein the pessary provides a flexure such that the first and second ends may reversibly contact one another.
5. The method of claim 1 wherein the pessary provides a flexure of one of the first and second ends of at least 3 cm with an oblique force of less than 200 grams when the other of the first and second ends is stationary.
6. The method of claim 1 wherein the pessary is a silicone rubber.
7. The method of claim 1 wherein the hardness of the substantially incompressible structure is between 30-40 durometer.
8. The method of claim 1 wherein the bridge arches toward a posterior sidewall of the vagina to allow an underside of the bridge to support the mid-urethra.
9. The method of claim 1 further providing additional pessaries providing a kit of pessaries, each pessary defining a different length for insertion in different sizes of vaginas.
10. A pessary device for treating stress urinary incontinence comprising:
a bridge support extending along a first axis between a first end and a second end of the bridge support and arching along a second axis perpendicular to the axis;
a first grip portion at the first end and extending perpendicularly to the first and second axes and configured to engage a sidewall of a vagina;
a second grip portion at the second end and extending perpendicularly to the first and second axes and configured to latch onto an opposing sidewall of the vagina; and
wherein the bridge support is elastically deformable to bend at substantially a midpoint and to provide an outward force at the opposing first and second ends.
11. The device of claim 10 wherein the first and second grip portions have a cross section that is at least 1.5 times as wide as it is tall.
12. The device of claim 11 wherein the hardness of the bridge is between 30-40 durometer.
13. The device of claim 10 wherein a length of the bridge support defined by the distance between the first and second end is between 2.5-3.5 cm.
14. The device of claim 10 wherein the height of the bridge support defined by the distance between a top of the mid-section and the bottom of the first and second ends is approximately 1 cm.
15. A pessary device for treating stress urinary incontinence comprising:
a bridge dimensioned to extend across a human vaginal canal and having a first and second end configured to contact opposing sidewalls of the vaginal canal;
wherein the bridge is made of a substantially incompressible elastomer and configured to flex at substantially a midpoint of the bridge to allow insertion of the device into the vagina and to unflex to a length greater than the width of the vaginal canal to allow the first and second end to grip opposing sidewalls of the vaginal canal.
16. The device of claim 15 wherein the bridge forms a substantially obtuse angle when inserted into the vagina.
17. The device of claim 15 wherein the bridge is configured to flex to form a substantially acute angle to allow insertion of the device into the vagina.
18. The device of claim 15 wherein the midpoint of the bridge contacts the sidewall of the vaginal canal.
19. The device of claim 15 wherein the pessary is bounded by a rectangle wider than it is tall.
20. The device of claim 15 wherein the height and length have an aspect ratio of substantially 1:3.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/870,471 US20170086956A1 (en) | 2015-09-30 | 2015-09-30 | Foldable Pessary for Treatment of Stress Urinary Incontinence |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/870,471 US20170086956A1 (en) | 2015-09-30 | 2015-09-30 | Foldable Pessary for Treatment of Stress Urinary Incontinence |
Publications (1)
Publication Number | Publication Date |
---|---|
US20170086956A1 true US20170086956A1 (en) | 2017-03-30 |
Family
ID=58408580
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/870,471 Abandoned US20170086956A1 (en) | 2015-09-30 | 2015-09-30 | Foldable Pessary for Treatment of Stress Urinary Incontinence |
Country Status (1)
Country | Link |
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US (1) | US20170086956A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111616832A (en) * | 2020-06-25 | 2020-09-04 | 贵阳市第二人民医院 | A easily take type uterus support subassembly for gynaecology and obstetrics |
NL2025355B1 (en) * | 2020-04-16 | 2021-10-26 | Perfect Pessary B V | Pessary |
US11337788B2 (en) | 2017-01-24 | 2022-05-24 | Liv Labs Ine. | Stress urinary incontinence (SUI) device |
-
2015
- 2015-09-30 US US14/870,471 patent/US20170086956A1/en not_active Abandoned
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11337788B2 (en) | 2017-01-24 | 2022-05-24 | Liv Labs Ine. | Stress urinary incontinence (SUI) device |
NL2025355B1 (en) * | 2020-04-16 | 2021-10-26 | Perfect Pessary B V | Pessary |
CN111616832A (en) * | 2020-06-25 | 2020-09-04 | 贵阳市第二人民医院 | A easily take type uterus support subassembly for gynaecology and obstetrics |
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Legal Events
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |